Fibromyalgia TENS in Physical Therapy Study (TIPS):an embedded pragmatic clinical trial

纤维肌痛 TENS 物理治疗研究 (TIPS)：一项嵌入式实用临床试验

• 批准号: 10701211
• 负责人: Leslie J Crofford
• 金额: $ 58.09万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-26 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10701211
• 关键词: Address; Adherence; Affect; Budgets; Caring; Case Report Form; Chronic; Clinical; Clinical Research; Clinical Trials; Communities; Data; Disease; Drug usage; Effectiveness; Electronic Health Record; Enrollment; Ensure; Exercise; Fatigue; Fibromyalgia; Future; Goals; Healthcare; Individual; Infrastructure; Insurance Carriers; Interdisciplinary Study; Interview; Laboratories; Manuals; Methods; Midwestern United States; Movement; Musculoskeletal Pain; Opioid; Pain; Pain management; Pathway interactions; Patients; Pharmaceutical Preparations; Phase; Physical therapy; Physical therapy exercises; Physiological; Placebos; Population; Postoperative Period; Pragmatic clinical trial; Primary Care Physician; Primary Health Care; Procedures; Process; Provider; Randomized; Randomized Controlled Trials; Recommendation; Research; Rural; Site; Sleep disturbances; Structure; Testing; Therapeutic; Therapeutic Intervention; Time; Training; Transcutaneous Electric Nerve Stimulation; Translating; Variant; Visit; Woman; Work; chronic pain; chronic pain patient; chronic painful condition; clinical practice; compare effectiveness; electronic consent; endogenous opioids; experience; fibromyalgia pain; fibromyalgia patients; implementation study; improved; meetings; opioid use; pain reduction; physical therapist; practice setting; pragmatic trial; primary outcome; recruit; secondary outcome; symptomatic improvement; tool; treatment as usual; Address; Adherence; Affect; Budgets; Caring; Case Report Form; Chronic; Clinical; Clinical Research; Clinical Trials; Communities; Data; Disease; Drug usage; Effectiveness; Electronic Health Record; Enrollment; Ensure; Exercise; Fatigue; Fibromyalgia; Future; Goals; Healthcare; Individual; Infrastructure; Insurance Carriers; Interdisciplinary Study; Interview; Laboratories; Manuals; Methods; Midwestern United States; Movement; Musculoskeletal Pain; Opioid; Pain; Pain management; Pathway interactions; Patients; Pharmaceutical Preparations; Phase; Physical therapy; Physical therapy exercises; Physiological; Placebos; Population; Postoperative Period; Pragmatic clinical trial; Primary Care Physician; Primary Health Care; Procedures; Process; Provider; Randomized; Randomized Controlled Trials; Recommendation; Research; Rural; Site; Sleep disturbances; Structure; Testing; Therapeutic; Therapeutic Intervention; Time; Training; Transcutaneous Electric Nerve Stimulation; Translating; Variant; Visit; Woman; Work; chronic pain; chronic pain patient; chronic painful condition; clinical practice; compare effectiveness; electronic consent; endogenous opioids; experience; fibromyalgia pain; fibromyalgia patients; implementation study; improved; meetings; opioid use; pain reduction; physical therapist; practice setting; pragmatic trial; primary outcome; recruit; secondary outcome; symptomatic improvement; tool; treatment as usual

Project Summary FM is a chronic pain condition characterized by widespread musculoskeletal pain, tenderness and stiffness associated with fatigue and sleep disturbance. The goal of reducing opioid use in patients with chronic pain requires that proven non-pharmacological treatments are applied in clinical practice. We have recently completed the FAST (Fibromyalgia Activity Study with TENS) trial demonstrating efficacy of Active TENS compared with Placebo TENS or No Treatment in women with fibromyalgia (FM). FAST was the first study to conclusively demonstrate efficacy of TENS in musculoskeletal pain. While physical therapists are trained in the use of TENS, it is underused in clinical practice. This application proposes to conduct an embedded pragmatic trial to compare effectiveness of physical therapy with or without the addition of TENS for FM patients within physical therapy (PT) practices as the study sites. The overall goal of this proposal is to (1) demonstrate the feasibility of adding TENS to treatment of patients with FM in a real-world PT practice setting and (2) to determine if addition of TENS to PT reduces pain, increases adherence to PT and allows patients with FM to reach their specific functional goals with less drug use. We hypothesize that using TENS in a PT setting is feasible and that FM patients using TENS are more likely to reach their therapeutic goals and reduce medication use. To test these hypotheses, we will utilize the following specific aims planning (UG3) and implementation (UH3) phases. UG3 Aim 1: Recruit physical therapy practices as research sites for this embedded pragmatic clinical trial and understand usual practice for patients with FM to inform trial processes. UG3 Aim 2: Ensure adequacy of infrastructure at potential study sites to complete a PT embedded pragmatic trial. UH3 Aim 1: Assess the feasibility of using TENS in addition to physical therapy for treatment of patients with FM using a cluster-randomized pragmatic clinical trial of routine PT (as selected by the therapist on an individual basis) with or without TENS. UH3 Aim 2: Determine if TENS use improves the symptoms of FM, increases adherence to physical therapy, increases the likelihood of meeting therapeutic goals, and reduces medication use. This study will address the critical need to develop a strategy for implementing effective non- pharmacologic treatments for FM. Our multi-disciplinary research team will leverage their experience from a recently completed randomized controlled trial and an implementation study for TENS in primary care practice to complete a real-world trial of TENS for FM in a PT setting. Successful completion of this trial will provide generalizable effectiveness data for referring providers, physical therapists, and insurers and will inform future pragmatic trials of non- pharmacologic treatments conducted in PT practices.

项目摘要 FM是一种慢性疼痛疾病，其特征是肌肉骨骼疼痛，压痛和僵硬相关 疲劳和睡眠障碍。减少慢性疼痛患者阿片类药物使用的目的需要证明 非药物治疗应用于临床实践。我们最近完成了快速（纤维肌痛 TENS的活动研究表明，与安慰剂数十个或没有治疗相比，有效数Tens的功效 纤维肌痛（FM）的女性。 FAST是第一个最终证明TEN在肌肉骨骼中有效性的研究 疼痛。尽管物理治疗师接受了TENS的培训，但它在临床实践中的用途不足。此应用程序 建议进行嵌入式务实试验，以比较有或没有的物理治疗的有效性 在物理疗法（PT）实践中增加了FM患者的TENS作为研究地点。总体目标 提案是（1）证明在现实世界中的PT实践中将FM患者的治疗添加到治疗的可行性 设置和（2）确定增加pt的数十是否会减轻疼痛，增加对PT的依从性，并允许患有患者 通过更少的吸毒，FM可以实现其特定的功能目标。我们假设在PT设置中使用TENS是可行的 而且，使用TENS的FM患者更有可能达到其治疗目标并减少药物使用。测试 这些假设，我们将利用以下特定目的计划（UG3）和实施（UH3）阶段。 UG3目标 1：招募物理疗法作为此嵌入式务实临床试验的研究站点，并了解常规 FM患者练习以告知试验过程。 UG3 AIM 2：在潜在研究中确保基础设施的充分性 要完成PT嵌入式务实试验的站点。 UH3 AIM 1：评估除了物理外使用TENS的可行性 使用常规PT的簇伴形的实用临床试验治疗FM患者的治疗（如选择 由治疗师单独的），有或没有数十个。 UH3 AIM 2：确定是否使用TENS是否有所改善 FM的症状，增加对物理治疗的依从性，增加实现治疗目标的可能性，并 减少用药的使用。这项研究将解决制定实施有效非 - 的策略的关键需求 FM的药理治疗。我们的多学科研究团队将利用他们最近的经验 完成了随机对照试验和针对初级保健实践中的数十个实施研究，以完成 在PT环境中FM的TENS的真实试验。成功完成此试验将提供可普遍的有效性 用于推荐提供者，物理治疗师和保险公司的数据，并将告知未来的非务实试验 在PT实践中进行的药理治疗。